FDA EIR - OpAns, LLC - August 03, 2015

An FDA inspection of OpAns, LLC, located in Durham, NC, was conducted on August 3, 2015. The abbreviated inspection, initiated under the FY15 Drug Workplan and CP 7356.002 (Drug Manufacturing Inspections), aimed to assess the firm's Quality and Laboratory Control Systems, with an expectation of finding Good Manufacturing Practice (GMP) related testing activities. However, the inspection determined that OpAns, LLC does not perform any GMP or lot release testing for products under the jurisdiction of the U.S. Food and Drug Administration. The firm's stability and lot release testing is exclusively for a synthetic stent product distributed solely in the European market, which is not approved by the FDA. OpAns primarily focuses on discovery/Research & Development support, along with other analytical services not regulated as drug manufacturing by the FDA. Consequently, no regulatory violations were identified related to FDA-regulated drug manufacturing or testing. The FDA investigators clarified that OpAns, LLC is not currently required to renew its drug registration, as its current operations do not involve activities necessitating registration under FDA authority. Management confirmed their understanding that if future operations involve the manufacture, release, or control of GMP drug or biological products for the U.S. market, the company would be required to register.